DeltaForm
Living mould chart DeltaForm in shade A3 containing: 5 upper and 5 lower posterior sets
26manufacturers in China registered for this device type
661catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (3), Hong Kong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Fuzhou Delphin BIO-Tech Co., Ltd. | Fuzhou | Fujian | Manufacturer | 18 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Heyuan HEY White Technology Co., Ltd. | Heyuan | Guangdong | Manufacturer | 12 |
| Beijing Yingguan Dental Science&Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 11 |
| Smile Dental Laboratory Company Limited | Zhuhai | Guangdong | Manufacturer | 11 |
Showing 12 of 26. All 26 manufacturers in China registered for Denture, Plastic, Teeth
Record
| Listed by | Merz Dental Gmbh, Germany |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Establishment | Manufacturer |
| 510(k) | K030588 |
| Record published | 2018-05-18 |
| Record revised | 2025-12-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| anteriors; shade B4; mould T2 | In distribution | |
| anteriors; shade A1; mould I4 | In distribution | |
| posteriors; shade B4; size L; upper jaw | In distribution | |
| posteriors; shade A4; size XS; upper jaw | In distribution | |
| posteriors; shade C4; size XS; lower jaw | In distribution | |
| posteriors; shade A3; size XL; upper jaw | In distribution | |
| anteriors; shade B3; mould S2 | In distribution | |
| anteriors; shade A3; mould S6 | In distribution | |
| posteriors; shade A3; size M; upper jaw | In distribution | |
| anteriors; shade C1; mould S2 | In distribution | |
| posteriors; shade A3; size S; lower jaw | In distribution | |
| anteriors; shade D4; mould I7 | In distribution | |
| posteriors; shade B3; size M; upper jaw | In distribution | |
| anteriors; shade A2; mould R3 | In distribution | |
| posteriors; shade A2; size XL; upper jaw | In distribution | |
| anteriors; shade A4; mould I6 | In distribution | |
| anteriors; shade C3; mould S1 | In distribution | |
| anteriors; shade B1; mould O1 | In distribution | |
| posteriors; shade D3; size L; upper jaw | In distribution | |
| anteriors; shade A1; mould R6 | In distribution | |
| anteriors; shade C2; mould I1 | In distribution | |
| anteriors; shade D3; mould R4 | In distribution | |
| posteriors; shade B1; size M; lower jaw | In distribution | |
| anteriors; shade D2; mould R1 | In distribution | |
| anteriors; shade BL2; mould R1 | In distribution | |
| anteriors; shade A3; mould S3 | In distribution | |
| anteriors; shade B2; mould O1 | In distribution | |
| anteriors; shade BL4; mould R4 | In distribution | |
| posteriors; shade D3; size S; upper jaw | In distribution | |
| anteriors; shade A3.5; mould T2 | In distribution | |
| anteriors; shade C3; mould I4 | In distribution | |
| anteriors; shade B4; mould I7 | In distribution | |
| anteriors; shade B1; mould I4 | In distribution | |
| posteriors; shade C2; size M; lower jaw | In distribution | |
| anteriors; shade C1; mould I3 | In distribution | |
| posteriors; shade BL4; size XL; lower jaw | In distribution | |
| posteriors; shade B4; size S; upper jaw | In distribution | |
| posteriors; shade BL3; size M; upper jaw | In distribution | |
| anteriors; shade A2; mould R1 | In distribution | |
| anteriors; shade A2; mould R5 | In distribution | |
| anteriors; shade A4; mould I3 | In distribution | |
| anteriors; shade C2; mould R2 | In distribution | |
| anteriors; shade B2; mould R6 | In distribution | |
| anteriors; shade B4; mould S5 | In distribution | |
| anteriors; shade A3.5; mould S4 | In distribution | |
| anteriors; shade B3; mould R1 | In distribution | |
| anteriors; shade D3; mould R2 | In distribution | |
| posteriors; shade D2; size M; upper jaw | In distribution | |
| anteriors; shade A3; mould R3 | In distribution | |
| anteriors; shade C1; mould I6 | In distribution | |
| posteriors; shade D4; size XL; lower jaw | In distribution | |
| anteriors; shade B2; mould I3 | In distribution | |
| anteriors; shade C4; mould R3 | In distribution | |
| anteriors; shade BL2; mould I8 | In distribution | |
| anteriors; shade A4; mould R4 | In distribution | |
| anteriors; shade B3; mould T2 | In distribution | |
| posteriors; shade B2; size XL; upper jaw | In distribution | |
| anteriors; shade A3; mould S2 | In distribution | |
| anteriors; shade C1; mould S3 | In distribution | |
| posteriors; shade A3; size L; lower jaw | In distribution | |
| anteriors; shade C1; mould I7 | In distribution | |
| anteriors; shade BL1; mould I4 | In distribution | |
| anteriors; shade A4; mould I8 | In distribution | |
| anteriors; shade A4; mould I7 | In distribution | |
| posteriors; shade A1; size M; upper jaw | In distribution | |
| anteriors; shade D3; mould T1 | In distribution | |
| anteriors; shade D4; mould I4 | In distribution | |
| anteriors; shade BL4; mould T1 | In distribution | |
| posteriors; shade B2; size M; upper jaw | In distribution | |
| anteriors; shade BL1; mould I6 | In distribution | |
| anteriors; shade B2; mould I2 | In distribution | |
| posteriors; shade BL1; size XS; upper jaw | In distribution | |
| posteriors; shade A4; size M; upper jaw | In distribution | |
| posteriors; shade B1; size XS; lower jaw | In distribution | |
| anteriors; shade BL2; mould S5 | In distribution | |
| posteriors; shade D2; size L; lower jaw | In distribution | |
| anteriors; shade C4; mould S1 | In distribution | |
| anteriors; shade C3; mould I5 | In distribution | |
| anteriors; shade BL4; mould R6 | In distribution | |
| posteriors; shade BL4; size XS; lower jaw | In distribution | |
| anteriors; shade B3; mould O1 | In distribution | |
| anteriors; shade C1; mould S4 | In distribution | |
| anteriors; shade BL3; mould R4 | In distribution | |
| posteriors; shade BL3; size S; upper jaw | In distribution | |
| anteriors; shade C4; mould I3 | In distribution | |
| anteriors; shade C3; mould I2 | In distribution | |
| posteriors; shade BL3; size XS; upper jaw | In distribution | |
| anteriors; shade D3; mould S3 | In distribution | |
| anteriors; shade C3; mould R4 | In distribution | |
| anteriors; shade B4; mould I2 | In distribution | |
| anteriors; shade C2; mould O1 | In distribution | |
| anteriors; shade BL2; mould I5 | In distribution | |
| posteriors; shade A4; size L; upper jaw | In distribution | |
| anteriors; shade B2; mould I8 | In distribution | |
| anteriors; shade C2; mould S3 | In distribution | |
| anteriors; shade BL2; mould S4 | In distribution | |
| posteriors; shade B1; size XL; lower jaw | In distribution | |
| anteriors; shade C1; mould I4 | In distribution | |
| posteriors; shade A3.5; size XL; upper jaw | In distribution | |
| anteriors; shade D2; mould S4 | In distribution | |
| anteriors; shade A4; mould R6 | In distribution | |
| anteriors; shade C1; mould S1 | In distribution | |
| anteriors; shade D2; mould R5 | In distribution | |
| anteriors; shade B2; mould R2 | In distribution | |
| posteriors; shade A3.5; size XL; lower jaw | In distribution | |
| anteriors; shade BL2; mould S1 | In distribution | |
| anteriors; shade A2; mould S5 | In distribution | |
| anteriors; shade B2; mould S4 | In distribution | |
| posteriors; shade C4; size L; upper jaw | In distribution | |
| posteriors; shade BL4; size XL; upper jaw | In distribution | |
| anteriors; shade A2; mould T2 | In distribution | |
| posteriors; shade B3; size S; upper jaw | In distribution | |
| anteriors; shade C1; mould I1 | In distribution | |
| anteriors; shade B1; mould I5 | In distribution | |
| anteriors; shade B2; mould R5 | In distribution | |
| posteriors; shade A3.5; size M; upper jaw | In distribution | |
| anteriors; shade B1; mould S4 | In distribution | |
| posteriors; shade BL3; size L; upper jaw | In distribution | |
| anteriors; shade D4; mould I5 | In distribution | |
| anteriors; shade BL1; mould S1 | In distribution | |
| anteriors; shade A3; mould I8 | In distribution | |
| anteriors; shade A3; mould S4 | In distribution | |
| anteriors; shade A3; mould I7 | In distribution | |
| posteriors; shade A3.5; size XS; lower jaw | In distribution | |
| anteriors; shade B3; mould S1 | In distribution | |
| posteriors; shade B2; size XL; lower jaw | In distribution | |
| anteriors; shade BL2; mould T1 | In distribution | |
| anteriors; shade B3; mould S3 | In distribution | |
| anteriors; shade B3; mould I5 | In distribution | |
| anteriors; shade B1; mould R5 | In distribution | |
| anteriors; shade A4; mould S4 | In distribution | |
| anteriors; shade D2; mould I2 | In distribution | |
| posteriors; shade BL2; size M; lower jaw | In distribution | |
| anteriors; shade D3; mould I8 | In distribution | |
| anteriors; shade C2; mould S2 | In distribution | |
| anteriors; shade C2; mould R3 | In distribution | |
| anteriors; shade A1; mould R2 | In distribution | |
| anteriors; shade C3; mould I3 | In distribution | |
| anteriors; shade BL3; mould S3 | In distribution | |
| anteriors; shade C3; mould I1 | In distribution | |
| posteriors; shade D4; size XS; lower jaw | In distribution | |
| anteriors; shade B4; mould I8 | In distribution | |
| anteriors; shade C1; mould R6 | In distribution | |
| anteriors; shade BL2; mould S6 | In distribution | |
| posteriors; shade B1; size M; upper jaw | In distribution | |
| anteriors; shade A1; mould I7 | In distribution | |
| anteriors; shade A3.5; mould R6 | In distribution | |
| anteriors; shade B1; mould I8 | In distribution | |
| posteriors; shade A3; size XS; upper jaw | In distribution | |
| posteriors; shade BL2; size M; upper jaw | In distribution | |
| anteriors; shade BL4; mould S3 | In distribution | |
| anteriors; shade A4; mould T1 | In distribution | |
| anteriors; shade C2; mould I6 | In distribution | |
| anteriors; shade A4; mould S1 | In distribution | |
| anteriors; shade B3; mould I2 | In distribution | |
| anteriors; shade C4; mould I1 | In distribution | |
| anteriors; shade C4; mould R2 | In distribution | |
| posteriors; shade D2; size XS; lower jaw | In distribution | |
| anteriors; shade BL3; mould I3 | In distribution | |
| posteriors; shade BL1; size XL; upper jaw | In distribution | |
| anteriors; shade BL1; mould S5 | In distribution | |
| anteriors; shade BL1; mould R5 | In distribution | |
| posteriors; shade BL3; size L; lower jaw | In distribution | |
| anteriors; shade BL4; mould R3 | In distribution | |
| posteriors; shade BL2; size XL; upper jaw | In distribution | |
| posteriors; shade A4; size XS; lower jaw | In distribution | |
| posteriors; shade BL1; size L; upper jaw | In distribution | |
| anteriors; shade D4; mould R2 | In distribution | |
| anteriors; shade C3; mould R2 | In distribution | |
| posteriors; shade B2; size M; lower jaw | In distribution | |
| anteriors; shade D3; mould O1 | In distribution | |
| anteriors; shade B3; mould R4 | In distribution | |
| anteriors; shade C2; mould I2 | In distribution | |
| posteriors; shade D4; size S; upper jaw | In distribution | |
| anteriors; shade A2; mould S2 | In distribution | |
| anteriors; shade C4; mould R5 | In distribution | |
| anteriors; shade BL3; mould T1 | In distribution | |
| anteriors; shade A1; mould I5 | In distribution | |
| posteriors; shade B2; size S; upper jaw | In distribution | |
| anteriors; shade B2; mould I7 | In distribution | |
| anteriors; shade A2; mould I8 | In distribution | |
| posteriors; shade A2; size XS; upper jaw | In distribution | |
| anteriors; shade B4; mould S3 | In distribution | |
| posteriors; shade B2; size XS; lower jaw | In distribution | |
| posteriors; shade B2; size S; lower jaw | In distribution | |
| anteriors; shade BL1; mould I2 | In distribution | |
| posteriors; shade D2; size M; lower jaw | In distribution | |
| anteriors; shade D4; mould I8 | In distribution | |
| posteriors; shade C1; size S; upper jaw | In distribution | |
| anteriors; shade C3; mould I7 | In distribution | |
| anteriors; shade C3; mould S6 | In distribution | |
| anteriors; shade C3; mould R5 | In distribution | |
| anteriors; shade D3; mould I3 | In distribution | |
| posteriors; shade D4; size M; upper jaw | In distribution | |
| anteriors; shade A2; mould O1 | In distribution | |
| anteriors; shade BL1; mould I5 | In distribution | |
| anteriors; shade D2; mould I7 | In distribution | |
| posteriors; shade D2; size XL; upper jaw | In distribution | |
| anteriors; shade B1; mould I6 | In distribution | |
| anteriors; shade C1; mould I2 | In distribution | |
| anteriors; shade B1; mould S5 | In distribution | |
| anteriors; shade C3; mould R1 | In distribution | |
| anteriors; shade BL3; mould R2 | In distribution | |
| anteriors; shade C2; mould I3 | In distribution | |
| posteriors; shade B1; size S; lower jaw | In distribution | |
| posteriors; shade A1; size S; lower jaw | In distribution | |
| anteriors; shade D3; mould I6 | In distribution | |
| posteriors; shade B2; size L; lower jaw | In distribution | |
| posteriors; shade D3; size M; upper jaw | In distribution | |
| anteriors; shade BL2; mould R5 | In distribution | |
| Living mould chart DeltaForm A3 | In distribution | |
| anteriors; shade B4; mould S2 | In distribution | |
| posteriors; shade C2; size M; upper jaw | In distribution | |
| posteriors; shade A3.5; size XS; upper jaw | In distribution | |
| anteriors; shade D4; mould I6 | In distribution | |
| anteriors; shade A3.5; mould R3 | In distribution | |
| anteriors; shade B2; mould I1 | In distribution | |
| anteriors; shade C2; mould R4 | In distribution | |
| posteriors; shade C4; size M; lower jaw | In distribution | |
| anteriors; shade B4; mould S4 | In distribution | |
| anteriors; shade BL3; mould R3 | In distribution | |
| anteriors; shade B2; mould I5 | In distribution | |
| anteriors; shade D4; mould R5 | In distribution | |
| posteriors; shade A1; size L; lower jaw | In distribution | |
| anteriors; shade BL1; mould I8 | In distribution | |
| anteriors; shade A3; mould R6 | In distribution | |
| anteriors; shade A1; mould I8 | In distribution | |
| anteriors; shade A1; mould R5 | In distribution | |
| anteriors; shade C4; mould O1 | In distribution | |
| anteriors; shade D4; mould S4 | In distribution | |
| anteriors; shade B3; mould S6 | In distribution | |
| posteriors; shade BL1; size M; upper jaw | In distribution | |
| anteriors; shade B1; mould R2 | In distribution | |
| anteriors; shade B2; mould I6 | In distribution | |
| anteriors; shade C2; mould S1 | In distribution | |
| anteriors; shade D2; mould R2 | In distribution | |
| anteriors; shade BL4; mould R5 | In distribution | |
| posteriors; shade C1; size XL; upper jaw | In distribution | |
| anteriors; shade A3.5; mould S1 | In distribution | |
| anteriors; shade B3; mould I1 | In distribution | |
| posteriors; shade B3; size L; upper jaw | In distribution | |
| anteriors; shade BL3; mould I6 | In distribution | |
| anteriors; shade B3; mould T1 | In distribution | |
| anteriors; shade C2; mould I5 | In distribution | |
| anteriors; shade C1; mould S6 | In distribution | |
| posteriors; shade BL1; size L; lower jaw | In distribution | |
| anteriors; shade B1; mould R6 | In distribution | |
| anteriors; shade D4; mould I3 | In distribution | |
| posteriors; shade C4; size XS; upper jaw | In distribution | |
| anteriors; shade C3; mould T1 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resin Teeth DCL PE | Ivoclar Vivadent Aktiengesellschaft | 8,657 |
| Primodent | Polident d.o.o. | 3,814 |
| Resin Teeth S PE S DCL | Ivoclar Vivadent Aktiengesellschaft | 2,870 |
| Vitapan | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2,480 |
| Myerson Special | The Myerson Company Limited | 2,386 |
| Kenson | The Myerson Company Limited | 2,365 |
| Candulor TCR | Candulor, AG | 1,944 |
| Vita Physiodens | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 1,788 |
| Portrait® IPN® Anteriors | Dentsply LLC | 1,674 |
| Enigma Denture Teeth – Pairs | Davis Schottlander & Davis, Ltd. | 1,632 |
| Ivostar Gnathostar | Ivoclar Vivadent Aktiengesellschaft | 1,501 |
| REF-Line | Polident d.o.o. | 1,458 |
Showing 12 of 9,979. All products under Denture, Plastic, Teeth
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120404 | 2012-05-21 |
| K030588 | 2003-05-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.